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Enzyme Therapy

Pegloticase + Methotrexate for Gout

Phase 4

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is comparing two different dosing schedules of pegloticase with methotrexate in patients with uncontrolled refractory gout. The main goal is to see if the higher dose of

Who is the study for?

Adults over 18 with uncontrolled refractory gout, who have high uric acid levels and haven't responded to standard treatments. Participants must stop any oral gout medications before starting the trial and use contraception if necessary. Women of childbearing potential need negative pregnancy tests.

What is being tested?

The study is testing whether giving Pegloticase every four weeks with Methotrexate (MTX) is as effective as every two weeks for reducing uric acid in gout patients. The first half is blinded, then all get the four-week treatment for another six months.

What are the potential side effects?

Pegloticase can cause reactions like rash or pain at the injection site, nausea, headache, and possible flare-ups of gout symptoms. Methotrexate may lead to liver issues, mouth sores, low blood cell counts, and lung problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pegloticase + Methotrexate Q4WExperimental Treatment2 Interventions

16 mg pegloticase will be administered intravenously every 4 weeks for 24 weeks during double blind treatment and 24 weeks during open label.

Group II: Pegloticase + Methotrexate Q2WExperimental Treatment2 Interventions

8 mg pegloticase will be administered intravenously every 2 weeks for 24 weeks during double blind treatment and 16 mg pegloticase every 4 weeks for 24 weeks during open label.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2019

Completed Phase 4

~4400

Pegloticase

2021

Completed Phase 4

~610